510(k) · Cleared
ClearedNeuroSENSE Monitoring System, Model NS-901
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Neurowave Systems, Inc. · OLW Index-Generating Electroencephalograph Software
Cleared on Aug 5, 2021 as substantially equivalent to K072286 (Aspect Medical Systems, Inc., 2007) after a 329-day review. Its family tree reaches back 9 generations to 1996.
- Decided
- Aug 5, 2021
- Review
- 329 days
- Class
- Class II
- Product code
- OLW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 9 generations to K963644 (1996). 14 ancestors in all, the oldest K923043 (1992). No later device cites it as a predicate yet.
- Root · 9 generations backK963644 A-1000 Eeg Monitor and a-1050 Eeg MonitorAspect Medical Systems, Inc. · 1996
- 5 generations between
- 3 generations backK052362 Bis Eeg Monitor, Model a-3000Aspect Medical Systems, Inc. · 2005
- 2 generations backK062613 Bis Eeg Monitor ViewAspect Medical Systems, Inc. · 2007
- 1 generation backK072286 Bis Eeg Vista Monitor System and BisxAspect Medical Systems, Inc. · 2007 · Recalled
- This deviceK202621 NeuroSENSE Monitoring System, Model NS-901Neurowave Systems, Inc. · 2021
Show all 9 generations
- Root · 9 generations backK963644 A-1000 Eeg Monitor and a-1050 Eeg MonitorAspect Medical Systems, Inc. · 1996
- 8 generations backK974496 A-2000 Eeg Monitor with BisAspect Medical Systems, Inc. · 1998
- 7 generations backK012466 Bis/Eeg ModuleGeneral Electric Medical Systems Information Techn · 2001
- 6 generations backK031694 Modification to Eeg Monitor with Bis, Model a-2000Aspect Medical Systems, Inc. · 2003
- 5 generations backK030267 Eeg Monitor with Bis, Model a-2000Aspect Medical Systems, Inc. · 2004
- 4 generations backK040183 BISXAspect Medical Systems, Inc. · 2004
- 3 generations backK052362 Bis Eeg Monitor, Model a-3000Aspect Medical Systems, Inc. · 2005
- 2 generations backK062613 Bis Eeg Monitor ViewAspect Medical Systems, Inc. · 2007
- 1 generation backK072286 Bis Eeg Vista Monitor System and BisxAspect Medical Systems, Inc. · 2007 · Recalled
- This deviceK202621 NeuroSENSE Monitoring System, Model NS-901Neurowave Systems, Inc. · 2021
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K963644 | A-1000 Eeg Monitor and a-1050 Eeg Monitor | Aspect Medical Systems, Inc. | 1996 | — |
| −8 | K974496 | A-2000 Eeg Monitor with Bis | Aspect Medical Systems, Inc. | 1998 | — |
| −7 | K012466 | Bis/Eeg Module | General Electric Medical Systems Information Techn | 2001 | — |
| −6 | K031694 | Modification to Eeg Monitor with Bis, Model a-2000 | Aspect Medical Systems, Inc. | 2003 | — |
| −5 | K030267 | Eeg Monitor with Bis, Model a-2000 | Aspect Medical Systems, Inc. | 2004 | — |
| −4 | K040183 | BISX | Aspect Medical Systems, Inc. | 2004 | — |
| −3 | K052362 | Bis Eeg Monitor, Model a-3000 | Aspect Medical Systems, Inc. | 2005 | — |
| −2 | K062613 | Bis Eeg Monitor View | Aspect Medical Systems, Inc. | 2007 | — |
| −1 | K072286 | Bis Eeg Vista Monitor System and Bisx | Aspect Medical Systems, Inc. | 2007 | 1 |
| 0 (this device) | K202621 | NeuroSENSE Monitoring System, Model NS-901 | Neurowave Systems, Inc. | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 2 | 0 |
| 2005 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in OLW? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new OLW device
- #1 K260880 SedLine Sedation Monitorscore 17.0 · 19 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K072286 | Bis Eeg Vista Monitor System and BisxSummary page 4…OLW Subsequent Product Codes: OMC, OLT, ORT, GXY Device Class: Class II 5.2 Predicate Device 510(k) Number: K072286 Manufacturer: Aspect Medical Systems Inc. Trade Name: BIS EEG VISTA MONITOR SYSTEM 5.3 D… | 2007 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 25 years and passes through 3 companies; a new generation was cleared every 1.5 years on median.
- 1 of the 14 ancestors has a recall of any class.
- 4 other devices also cite its predicate K072286.
How does its category compare?
All OLW devicesOLW Index-Generating Electroencephalograph Software: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, this device’s year, is highlighted.
FDA decisions per year · OLW
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · OLW
105in 2007
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · OLW
No recall names OLW since 2007.
Adverse event reports per year · OLW
73in 2025
MAUDE reports naming product code OLW, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 3 | 105 | 0 | 0 |
| 2008 | 2 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 1 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 3 |
| 2018 | 1 | — | 0 | 3 |
| 2019 | 0 | — | 0 | 6 |
| 2020 | 0 | — | 0 | 15 |
| 2021 | 1 | — | 0 | 15 |
| 2022 | 1 | — | 0 | 27 |
| 2023 | 1 | — | 0 | 18 |
| 2024 | 1 | — | 0 | 93 |
| 2025 | 0 | — | 0 | 73 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
The NeuroSENSE Monitoring System, Model NS-901, is intended for monitoring the brain state of adult and pediatric patients (18 years of age and older) in the operating room and other clinical settings by acquiring electroencephalographic (EEG) signals.
The WAVens Index, a quantifier of EEG activity calculated and displayed by the NeuroSENSE NS-901 Monitor, may be used as an aid in monitoring the hypnotic effect of anesthetics. The anesthetics include inhaled anesthetics and propofol in combination with opioids.
The NeuroSENSE Monitor is intended to be used under the direction and interpretation of a qualified medical professional.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K202621 · printed Nov 6, 2026
Cite this page
510(k) Report. “K202621: NeuroSENSE Monitoring System, Model NS-901.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K202621
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026